Systems and methods for transnasal dilation of passageways in the ear, nose or throat

ABSTRACT

A dilation catheter device and system for dilating an opening in a paranasal sinus and/or other passageways within the ear, nose or throat is disclosed. A dilation catheter device and system is constructed in a manner that facilitates ease of use by the operator and, in at least some cases, allows the dilation procedure to be performed by a single operator. Additionally, the dilation catheter device and system may be useable in conjunction with an endoscope and/or a fluoroscope to provide for easy manipulation and positioning of the devices and real time visualization of the entire procedure or selected portions thereof. In some embodiments, shaft markers are disposed on a shaft of the dilation catheter and have a light color to contrast with a dark color of the dilation catheter shaft. The high contrast between the markers and catheter shaft allows for easy viewing of the markers in low light and operation conditions.

RELATED APPLICATIONS

This application is a division of U.S. patent application Ser. No.12/496,226, entitled “Systems and Methods for Transnasal Dilation ofPassageways in the. Ear, Nose or Throat,” filed Jul. 1, 2009, which is acontinuation in part of U.S. patent application Ser. No. 11/789,704entitled “Systems and Methods for Transnasal Dilation of Passageways inthe Ear, Nose and Throat,” filed Apr. 24, 2007, issued as U.S. Pat. No.8,747,389 on Jun. 10, 2014, which is a continuation in part of U.S.patent application Ser. No. 11/355,512 entitled “Devices, Systems andMethods Useable for Treating Frontal Sinusitis,” filed Feb. 16, 2006,issued as U.S. Pat. No. 8,894,614 on Nov. 25, 2014, which is a is acontinuation in part of Ser. No. 11/150,847 entitled “Devices, Systemsand Methods Useable for Treating Sinusitus,” filed on Jun. 10, 2005,issued as U.S. Pat. No. 7,803,150 on Sep. 28, 2010, which is acontinuation in part of Ser. No. 10/944,270 entitled “Apparatus andMethods for Dilating and Modifying Ostia of Paranasal Sinuses and OtherIntranasal or Paranasal Structures,” filed on Sep. 17, 2004, whichpublished as U.S. Publication No. 2006/0004323 on Jan. 5, 2006, which isa continuation in part of Ser. No. 10/829,917 entitled “Devices, Systemsand Methods for Diagnosing and Treating Sinusitis and Other Disorders ofthe Ears, Nose and/or Throat,” filed on Apr. 21, 2004, issued as U.S.Pat. No. 7,654,997 on Feb. 2, 2010, the entire disclosures of each suchapplication being expressly incorporated herein by reference.

FIELD OF INVENTION

The present invention relates generally to medical devices and methodsand particularly to balloon catheters and other devices that may beinserted through the nose and used to dilate the ostia of paranasalsinuses for treatment of sinusitis.

BACKGROUND

The paranasal sinuses are hollow cavities in the skull connected bysmall openings, known as ostia, to the nasal canal. Normally, air passesinto and out of the paranasal sinuses through the ostia. Also, mucus iscontinually formed by the mucosal lining of the sinus and drains throughthe ostia and into the nasal canal.

Sinusitis is a general term that refers to inflammation in one or moreof the paranasal sinuses. Acute sinusitis can be associated with upperrespiratory infections or allergic conditions which cause tissueswelling and temporarily impedes normal trans-ostial drainage andventilation of the sinuses, thereby resulting in some collection ofmucous and possibly infection within the sinus cavities. Chronicsinusitis is a long term condition characterized by persistent or longterm narrowing or blockage of the sinus ostia, resulting in chronicinfection and inflammation of the sinuses. Chronic sinusitis is oftenassociated with long standing respiratory allergies, nasal polyps,hypertrophic nasal turbinates and/or deviated internasal septum. Whileacute sinusitis is typically caused by infection with a single pathogen(e.g., one type of bacteria, one type of virus, one type of fungus,etc.), chronic sinusitis is often associated with multiple pathogeninfections (e.g., more than one type of bacteria or more than genus ofmicroorganism).

Chronic sinusitis, if left untreated, can result in irreparable damageto the tissues and/or bony structures of the paranasal anatomy. Theinitial treatment of chronic sinusitis usually involves the use of drugssuch as decongestants, steroid nasal sprays and antibiotics (if theinfection is bacterial). In cases where drug treatment alone fails toprovide permanent relief, surgical intervention may be indicated.

Functional endoscopic sinus surgery (FESS) is commonly performed use anendoscope and various rigid instruments inserted through the patient'snostril. The endoscope is used to visualize the positioning and use ofthe operative instruments to perform tasks intended to improve sinusdrainage, such as removal of polyps, straightening of deviated septumand excision of mucous membrane and bone to enlarge the narrow the sinusostia or to create new openings into the sinuses.

Recently the technique known as the Balloon Sinuplasty™ procedure hasbeen developed by Acclarent, Inc. of Menlo Park, Calif. for treatment ofsinusitis. A number of copending United States Patent Applications,including patent application Ser. Nos. 11/789,704, issued as U.S. Pat.No. 8,747,389 on Jun. 10, 2014, 11/355,512, issued as U.S. Pat. No.8,894,614 on Nov. 25, 2014, 11/150,847, issued as U.S. Pat. No.7,803,150 on Sep. 28, 2010, 10/944,270, published as U.S. PublicationNo. 2006/0004323 on Jan. 5, 2006, and 10/829,917, issued as U.S. Pat.No. 7,654,997 on Feb. 2, 2010, describe various embodiments of theBalloon Sinuplasty™ procedure as well as various devices useable in theperformance of such procedure. In the Balloon Sinuplasty™ procedure, aguide catheter is inserted into the nose and positioned within oradjacent to the ostium of the affected paranasal sinus. A guidewire isthen advanced through the guide catheter and into affected paranasalsinus. Thereafter, a dilation catheter having an expandable dilator(e.g., an inflatable balloon) is advanced over the guidewire to aposition where the dilator is positioned within the ostium of theaffected paranasal sinus. The dilator is then expanded causing dilationof the ostium and remodeling of bone adjacent to the ostium, withoutrequired incision of the mucosa or removal of any bone. The cathetersand guidewire are then removed and the dilated ostium allows forimproved drainage from and ventilation of the affected paranasal sinus.

patent application Ser. Nos. 11/789,704, issued as U.S. Pat. No.8,747,389 on Jun. 10, 2014, 11/355,512, issued as U.S. Pat. No.8,894,614 on Nov. 25, 2014, 11/150,847, issued as U.S. Pat. No.7,803,150 on Sep. 28, 2010, 10/944,270, published as U.S. PublicationNo. 2006/0004323 on Jan. 5, 2006, and 10/829,917, issued as U.S. Pat.No. 7,654,997 on Feb. 2, 2010, also describe methods for transnasaldilation of other passageways in the ear, nose and/or throat, such asthe Eustachian tube and nasolacrimal duct.

In one embodiment, there is provided a dilation catheter device andsystem that is useable for dilating the ostium of a paranasal sinus, orother passageway within the ear, nose or throat. This dilation catheterdevice and system is constructed in a manner that facilitates ease ofuse by the operator and, in at least some cases, allows the dilationprocedure to be performed by a single operator, thereby minimizing thenumber of personnel required for the procedure. Additionally, thedilation catheter device and system of the present invention is useablein conjunction with an endoscope and/or a fluoroscope to provide foreasy manipulation and positioning of the devices and real timevisualization of the entire procedure or selected portions thereof. Insome embodiments, an optional handle may be attached to the dilationcatheter or to a guide catheter through which the dilation catheter isinserted and such handle may be graspable along with another device(e.g., an endoscope) by a single hand. In this manner, the operator maycontrol the dilation catheter and another device (e.g., an endoscope)with one hand while being free to use his other hand for other purposes.

Further in one embodiment, there are provided systems for treating adisease or disorder of the ear, nose or throat of a human or animalsubject. Such systems generally comprise a guide catheter and a workingcatheter. The working catheter is advanceable through the guidecatheter. The guide catheter has a substantially rigid shaft and theworking catheter has a proximal portion that is substantially rigid. Theworking catheter also has a distal portion that is more flexible thanthe substantially rigid proximal portion. The working catheter is sizedrelative to the guide catheter so that, at least when the distal portionof the working catheter is advanced out of a distal opening of the guidecatheter and the working element is being used to perform a desireddiagnostic or therapeutic task, only the substantially rigid proximalportion (or some portion thereof) will extend out of the proximalopening of the guide catheter. In some embodiments, the working cathetermay additionally be sized relative to the guide catheter so that theworking catheter is initially advanceable to a first position where itsdistal end of the working catheter has not yet emerged out of the distalend of the guide catheter but only the substantially rigid proximalportion of the working catheter is protruding out of the proximal end ofthe guide catheter.

Still further in accordance with another embodiment, there are providedsinus ostium dilation catheter devices that generally comprise anelongate catheter shaft having proximal shaft section that issubstantially rigid and a distal shaft section that is more flexiblethan the proximal shaft section. In some embodiments, the proximal shaftsection may extend along at least about 50% of the overall length of thedevice. A guidewire lumen extends through at least a portion of thecatheter shaft to facilitate advancement of the catheter over aguidewire. A dilator is located on the distal shaft section, suchdilator having a non-expanded configuration and an expandedconfiguration.

Still further in accordance with one embodiment, there are providedmethods for dilating the ostia of paranasal sinsus and other passagewayswithin the ear, nose or throat of a human or animal subject. In general,such methods comprise the steps of a) inserting a guide catheter havinga proximal end and a distal end through one of the subject's nostrilsand positioning the guide catheter within or near the passageway to bedilated, b) inserting, through the guide catheter, a dilation cathetercomprising i) an elongate catheter shaft having a proximal end, a distalend, a proximal shaft section that is substantially rigid and a distalshaft section that is more flexible than the proximal shaft section, ii)a guidewire lumen extending through at least a portion of the cathetershaft to facilitate advancement of the catheter over a that issubstantially rigid and a distal shaft section that is more flexiblethan the proximal shaft section, ii) a guidewire lumen extending throughat least a portion of the catheter shaft to facilitate advancement ofthe catheter over a guidewire and iii) a dilator located on the distalshaft section, said dilator being in a non-expanded configuration, c)positioning the dilator within the passageway and d) causing the dilatorto expand to an expanded configuration, thereby dilating the passageway.

In still a further embodiment, a balloon dilation catheter device isprovided that is useable for dilating an opening in a paranasal sinus.The dilation catheter device includes a catheter shaft having alongitudinal axis, an inflation lumen, a distal end, a proximal end, aproximal shaft section that is substantially rigid and a distal shaftsection that is more flexible than the proximal shaft section. Also, thecatheter shaft is dark in color. An inflatable balloon is disposed onthe distal shaft section. The inflatable balloon is connected to theinflation lumen and the inflatable balloon has a non-circularcross-sectional shape when partially inflated. In this embodiment, theballoon dilation catheter includes a first proximal shaft markerdisposed on the proximal shaft section, and the first shaft markerhaving a significantly lighter color than the catheter shaft. The firstproximal shaft marker allows a user to approximate, using directvisualization of the first proximal shaft marker, a position of theballoon relative to a guide catheter through which the balloon catheteris advanced. There is also a first distal shaft marker disposed on thedistal shaft section proximal to a proximal end of the balloon and thefirst distal shaft marker has a significantly lighter color than thecatheter shaft. The first distal shaft marker enables a user toapproximate, using endoscopic visualization of the first distal shaftmarker, a position of the balloon relative to an opening of a paranasalsinus.

In one embodiment, a second proximal shaft marker is disposed on theproximal shaft section distally from the first proximal shaft marker andhaving a significantly lighter color than the catheter shaft. The firstproximal shaft marker has a greater length than the second proximalshaft marker. Further, the length of the first proximal shaft marker isequal to the length from a proximal end of the inflatable balloon to thedistal end of the catheter shaft. The first proximal shaft marker isspaced from the distal end of the catheter shaft such that it allows theuser to approximate when the distal end of the catheter shaft is locatedat a distal end of the guide catheter and when the proximal end of theballoon exits a guide catheter, and wherein the second proximal shaftmarker allows the user to approximate when the distal end of thecatheter shaft is located just proximal to a curve in the guide catheter

The balloon dilation catheter device may also include a second distalshaft marker disposed on the distal shaft section proximal to the firstdistal shaft marker and having a significantly lighter color than thecatheter shaft. The first distal shaft marker is disposed at a knowndistance proximally from the proximal end of the balloon, and the seconddistal shaft marker is disposed at a known distance proximally from thefirst distal shaft marker. Also, the first and second distal shaftmarkers have different appearances. In one embodiment, the first distalshaft marker is disposed approximately one centimeter from the proximalend of the balloon and the second distal shaft marker is disposedapproximately two centimeters from the proximal end of the balloon. Athird distal shaft marker also may be disposed on the distal shaftsection at the proximal end of the balloon.

The balloon dilation catheter device may also include a first radiopaquemarker disposed on the distal shaft section and within the inflatableballoon. There may be a second radiopaque marker disposed on the distalshaft section distally from the first radiopaque marker within theballoon. The first and second radiopaque markers are disposed a distanceapart from one another to indicate the effective length of theinflatable dilator.

Also, in one embodiment, the inflatable balloon of the balloon dilatorcatheter device has an approximately triangular cross-section in apartially inflated state. The balloon may also have a balloon neckextending from the balloon proximally along the catheter shaft. Theballoon neck allows an endoscopic marker to be disposed on the distalshaft section and underneath the balloon neck.

In an embodiment of a system for treating a disease or disorder of theear, nose or throat of a human or animal subject, the system includes aguide catheter that is insertable into a head of the subject and has asubstantially rigid shaft, a proximal opening, a distal opening and alumen extending between the proximal opening and the distal opening. Thesystem also includes a balloon catheter device as described above thatis advanceable out of the distal opening of the guide catheter. Theballoon catheter device also includes a guidewire lumen and the systemincludes a guidewire that is advanceable through the guidewire lumen.Also, the inflation lumen of the catheter shaft is sized so that, afterthe inflatable balloon has been inflated to a working diameter, theinflatable balloon will deflate in less than 5 seconds with applicationof negative pressure to the inflation lumen by a conventional ballooncatheter inflation and deflation device.

The system may also include an irrigation catheter sized for advancementthrough the guide catheter into a paranasal sinus.

Furthermore, in an embodiment of a method for dilating a naturalparanasal sinus ostium of a paranasal sinus of a patient, the methodincludes advancing a guide catheter into a head of a patient such that adistal end of the guide catheter is positioned within or near a naturalparanasal sinus ostium of a paranasal sinus. Also, the method includesinserting an endoscope into the patient's head and advancing a ballooncatheter through a lumen of the guide catheter such that a balloon ofthe catheter passes out of the distal end of the guide catheter. Withthe endoscope, a first distal shaft marker disposed on a shaft of theballoon catheter a first known distance from the balloon may be viewed,and also, a second distal shaft marker disposed on the shaft a secondknown distance from the balloon may be viewed. The method may includeapproximating a location of the balloon relative to the paranasal sinusostium, using the first and second distal shaft marker and their knowndistances from the balloon. The balloon of the balloon catheter may beexpanded to remodel or break bone underlying mucusa of the naturalparanasal sinus ostium and dilate the ostium.

The method may also include viewing a first proximal shaft marker duringthe step of advancing the balloon catheter. When a distal end of thefirst proximal shaft marker enters a proximal end of the guide cathetera distal end of the balloon catheter shaft is located approximately atthe distal end of the guide catheter. Also, when a proximal end of thedistal shaft marker enters the proximal end of the guide catheter aproximal end of the balloon of the catheter is located approximately atthe distal end of the guide catheter.

Further, the method includes viewing a second proximal shaft markerduring the step of advancing the balloon catheter. The second proximalshaft marker is disposed distal to the first proximal shaft marker, andwhen the second proximal shaft marker is located approximately at theproximal end of the guide catheter, the distal end of the ballooncatheter is located immediately proximal to a curve in the distal end ofthe guide catheter. The first distal shaft marker is located proximal tothe balloon and the second distal shaft marker is located distal to theballoon.

In another embodiment, the first and second distal shaft markers arelocated proximal to the balloon. The first distal shaft marker, may belocated approximately one centimeter proximal to a proximal end of theballoon and the second distal shaft marker may be located approximatelytwo centimeters proximal to the proximal end of the balloon. The methodmay also include viewing a third distal shaft marker located at theproximal end of the balloon.

The method may further include advancing a guidewire through the guideand through the ostium before advancing the balloon catheter. After theguidewire is in place, the balloon catheter is advanced over theguidewire and through the guide.

Also, the method may include removing the balloon catheter through theguide catheter and advancing an irrigation catheter through the guidecatheter into the paranasal sinus. Once the irrigation catheter is inposition, the sinus may be irrigated using the irrigation catheter.

Still further embodiments, aspects, features and details of the presentinvention will be understood upon reading of the detailed descriptionand examples set forth here below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of one embodiment of a dilation catheter with itsdilator in an expanded configuration.

FIG. 1A is a cross sectional view through line 1A-1A of FIG. 1 with anenlarged break-out view of a portion thereof.

FIG. 1B is an enlarged side view of the dilator and distal end of thedilation catheter of FIG. 1.

FIG. 2 shows a collection of transnasal guide catheters useable ascomponents of the system of the present invention.

FIG. 3 is a side view of one embodiment of a handle apparatus of thepresent invention.

FIG. 3A is a side view of another embodiment of a handle apparatus ofthe present invention.

FIG. 3B is a side view of yet another embodiment of a handle apparatusof the present invention.

FIG. 3C is a side view of yet another embodiment of a handle apparatusof the present invention.

FIG. 4 is an exploded, partial view of one embodiment of a dilationcatheter system of the present invention including an optional handleapparatus.

FIG. 5 is a schematic diagram of one embodiment of a dilation cathetersystem of the present invention (without the optional handle apparatus)being used to dilate the ostium of a paranasal sinus.

FIG. 6 is a schematic diagram of one embodiment of a dilation cathetersystem of the present invention (with the optional handle apparatus)being used to dilate the ostium of a paranasal sinus.

FIG. 7A shows a partial view of the system of FIG. 5 including aguidewire stop/connector apparatus of the present invention mounted onthe guidewire prior to advancement of the guidewire.

FIG. 7B shows a partial view of the system of FIG. 5 including aguidewire stop/connector apparatus of the present invention mounted onthe guidewire and engaged with the hub of the dilation catheterfollowing advancement of the guidewire.

FIG. 8A shows the dilation catheter system of FIG. 5 and an endoscopebeing held by one hand of the operator while the operator's other handis being used to advance the guidewire of the system into a paranasalsinus.

FIG. 8B shows the dilation catheter system of FIG. 6 and an endoscopebeing held by one hand of the operator while the operator's other handis being used to advance the dilation catheter so that its dilatorbecomes positioned within the ostium of the paranasal sinus.

FIG. 9 is a flow diagram showing steps in one method for using adilation catheter system of the present invention.

FIG. 10 is a flow diagram showing steps in another method for using adilation catheter system of the present invention.

FIG. 11 is a flow diagram showing steps in yet another method for usinga dilation catheter system of the present invention.

FIG. 12 is a side view of another embodiment of a dilation catheter withits dilator in an expanded configuration.

FIG. 12A is a cross sectional view through line 12A-12A of FIG. 12.

FIG. 12B is an enlarged side view of the dilator and distal end of thedilation catheter of FIG. 12.

DETAILED DESCRIPTION

The following detailed description and the accompanying drawings areprovided for the purpose of describing some, but not necessarily all,examples or embodiments of the invention. The contents of this detaileddescription and the accompanying drawings are exemplary in nature and donot limit the scope of the invention in any way.

A First Embodiment of a Dilation Catheter

FIGS. 1-1B show one example of a dilation catheter device 10 of thepresent invention with a guidewire GW operatively inserted therethrough.In this example, the dilation catheter device 10 comprises an elongatecatheter shaft 12 having a proximal shaft section 12prox that issubstantially rigid and a distal shaft section 12dist that is moreflexible than the proximal shaft section 12prox. An expandable dilator,such as a balloon 14 or other suitable mechanical or non-inflationaldilator, is mounted on the distal shaft section 12dist and a distal tipmember 18 protrudes beyond the distal end of the balloon 14, as shown.Also, a proximal T hub 16 is attached to the proximal end of theproximal shaft section 12prox. This proximal T hub 16 has a proximalLuer connector 20 and a side arm 22 having a female Luer connector thatextends substantially perpendicular to the longitudinal axis of the hub16, as shown. When compared to a typical Y hub, the side arm 22 of thisT hub is further away from the proximal Luer connector 20 and isoriented at a right angle to the proximal Luer connector 20. Thus,tubing connected to this perpendicular side arm 22 is less likely toobscure or block the proximal Luer connector 20 than in a typical Y huband the operator is less likely to confuse the proximal Luer connector20 with the Luer connector on the side arm 22.

Although, in the particular example shown in the drawings, theexpandable dilator comprises a balloon 14, it is to be appreciated thatvarious other types of expandable dilators such as expandable cages,struts and other expandable mechanical assemblies may be used as analternative to a balloon 14. Some non-limiting examples of expandabledilators other than balloons have previously been described in U.S.patent application Ser. Nos. 11/355,512, issued as U.S. Pat. No.8,894,614 on Nov. 25, 2014, 11/150,847, issued as U.S. Pat. No.7,803,150 on Sep. 28, 2010, 10/944,270, published as U.S. PublicationNo. 2006/0004323 on Jan. 5, 2006, and 10/829,917, issued as U.S. Pat.No. 7,654,997 on Feb. 2, 2010, which are expressly incorporated hereinby reference.

For use in teenage or adult humans, the overall length of the cathetershaft 12 may be in the range of about 15 cm to about 25 cm, the proximalshaft section 12prox may have a length in the range of about 10 cm toabout 15 cm and the distal shaft section 12dist may have a length in therange of about 5 cm to about 10 cm. In the particular example shown inthe drawings and described herein, the catheter shaft 12 has an overalllength of 21.2 cm, the proximal shaft section 12prox being 12.5 cm inlength and the distal shaft section 12dist being 8.7 cm in length. Theseoptimal lengths of the proximal shaft section 12prox and distal shaftsection 12dist have been arrived at based on a number of considerations,which will be discussed more fully herebelow in relation to theconcurrent use of this dilation catheter 10 with a trans-nasal guidecatheter.

As may be appreciated from the cross sectional view of FIG. 1A, theproximal shaft section 12prox comprises a rigid outer tube 30 a flexiblemiddle tube 32 disposed substantially coaxially within the lumen of therigid outer tube 30 and an inner tube 36 disposed substantiallycoaxially within the lumen of the middle tube 32. In this particularexample, the outer tube 30 is formed of stainless steel hypotube havingan outer diameter of 0.076 inches and an inner diameter of 0.068 inches.As an alternative to stainless steel hypotube, this outer tube 30 may beformed of rigid non-metallic material such as polyetheretherketone(PEEK) or other rigid plastics suitable for such application.Alternatively, other rigid reinforcing members may be used in, or inlieu of, the outer tube, such as wires (round, flat, square or of othercross section), partial tubes (e.g., arcs), etc. Also, in thisparticular example, the middle tube 32 is formed of Pebax having aninner diameter of 0.055 inches, an outer diameter of 0.065+/−0.003inches. The inner tube 36 is formed of polyether block copolymer tubing(e.g., Pebax® Resin, Arkema, Inc., Philadelphia, Pa.) having an innerdiameter of 0.038 inches, an outer diameter of 0.048 inches.

The outer tube 30 terminates at the end of the proximal shaft section12prox. The middle tube 32 and inner tube 36 extend beyond the distalend of the outer tube 30, forming the distal shaft section 12dist.

As seen in the enlarged break-out segment of FIG. 1A, a polyether blockcopolymer film laminate 31 (e.g., Pebax® Resin, Arkema, Inc.,Philadelphia, Pa.) is heat shrunk onto the outer surface of the cathetershaft 12 from the proximal hub 16 to the balloon 14. This laminate 31provides a smooth outer surface and smoothes the step-down in diameterfrom the distal end of the proximal shaft section 12prox to the proximalend of the distal shaft section 12dist (i.e., it provides a smoothsurface over the distal end of the outer tube 30 and the adjacent outersurface of the middle tube 32). The smooth step down may also be formedby an adhesive fillet. In other embodiments, the smooth step down may beformed by tapering or chamfering the structure of the distal end of theproximal shaft, eliminating the need for a laminate or adhesive.

The proximal end of the middle tube 32 extends into and is secured tothe hub 16, distal to side arm Luer connector 22. The proximal end ofthe inner tube 36 extends into and is secured within hub 16, proximal tothe side arm Luer connector 22 and in direct alignment and fluidcommunication with proximal Luer connector 20. The distal end of themiddle tube 32 terminates within the balloon 14 and the proximal end ofthe dilator is secured to the outer surface of the middle tube. Thedistal end of the inner tube 36 also extends through the balloon 14 andprotrudes distally beyond the balloon 14, forming the relativelyflexible distal tip member 18 as shown in FIG. 1. The distal end of theballoon 14 is secured to the outer surface of the inner tube 36. In thismanner, the inner tube lumen 38 extends through the entire cathetershaft 12 from the proximal Luer connector 20 through the distal tip 18and may be used a guidewire lumen or as a working lumen for infusion ofirrigation solution, medicaments, contrast media or other substancesand/or for aspiration of blood, fluids or debris. Guidewires that may beadvantageously used in conjunction with this dilation catheter 10 mayhave a length of 60 cm to 80 cm and may be either 0.014 inch or 0.035inch, such as those commercially available as the Relieva® SinusGuidewires (Acclarent, Inc., Menlo Park, Calif.) or sizes in betweensuch as 0.018 inch, 0.020 inch, or 0.033 inch. Although the drawingsshow an over-the-wire catheter having a guidewire lumen that extendsthrough the entire length of the catheter, it is to be appreciated thatguidewire lumens extending less than the entire length of the catheter(e.g., rapid exchange guidewire lumens) may be used as an alternative tothe over-the-wire lumen shown. Additionally, in some embodiments, ratherthan advancing the catheter over a guidewire, the catheter may beequipped with a fixed guidewire tip such as any of those described inU.S. patent application Ser. No. 11/438,090, issued as U.S. Pat. No.8,951,225 on Feb. 10, 2015, entitled Catheters with Non-Removable GuideMembers Useable for Treatment of Sinusitis, the entire disclosure ofwhich is expressly incorporated herein by reference.

The inner tube lumen 38 may be lined or coated with a lubriciousmaterial to facilitate passages of the guidewire GW through that lumen38. The diameter of the inner tube 36 may be changed to accommodateguidewires of different diameter. In the particular embodimentdescribed, the inner tube lumen 38 is sized to receive a 0.035 inchdiameter guidewire GW. The inner tube lumen 38 may be internally linedor coated with a 2% solution of linear polydimethylsiloxane (PDMS)(e.g., Dow Corning® 360 Medical Fluid, Dow Corning Corporation, Midland,Mich.) diluted in isopropyl alcohol or another silicone material (suchas a 2% solution of Dow-Corning MDX4-4159 in isopropyl alcohol). Thecoating is cured at room temperature.

The luminal space 34 between the outer surface of the inner tube 36 andthe inner surface of the middle tube 32 is in fluidic communication withthe side arm Luer connector 22 and extends to the interior of theballoon 14. Thus, this luminal space 34 serves as the passageway throughwhich inflation fluid is passes into and out of the balloon 14. The sizeof this luminal space 34 and the relatively short length of the cathetershaft 12 are optimized to minimize drag on inflation fluid passingthrough this luminal space 34 and allows for rapid deflation of theballoon 14. The clearance of 0.006 to 0.007 inches between the inner andouter member is desired for catheter length of 20-35 cm. The desireddeflation time is 5-10 seconds and the deflation time is measured withapplication of negative pressure on the inflation/deflation lumen usinga 20 cc inflation device that is filled with 10 cc contrast/salinemixture.

Balloon Construction and Coating

FIG. 1B shows details of the balloon 14. In this example, the balloon 14is a noncompliant balloon formed of polyethylene teraphthalate (PET)film having a thickness of 0.8 mils. The balloon 14 has a cylindricalmidregion 44 and tapered proximal and distal end regions 46prox and46dist. The balloon 14 has an overall length of 2.6 cm. The cylindricalmidregion 44 of the balloon 14 has a length of 16 mm (i.e., the “workinglength”) and each tapered end region 46prox, 46dist has a length of 5mm. The balloon 44 has a burst pressure of at least 14 to 16_atmospheres. The outer diameter of the balloon 14, when inflated to apressure of 14 atmospheres, may be in the range of 5.0 mm to 5.5 mm. Inthis particular example, the balloon 14 is sized for dilation of theostia of paranasal sinuses and such balloon 14 is offered in sizeshaving outer diameters of 5 mm or 7 mm when inflated to a pressure of 14atmospheres. Dilation 15 catheters 10 having the 5 mm diameter balloon14 may be more suitable for use in subjects of small body size whiledilation catheters 10 having the 7 mm diameter balloon 14 may be moresuitable for use in subjects having a large body size. Smaller or largerballoons may be used for dilating structures other than the ostia ofparanasal sinuses (e.g., Eustachian tube or naso-lacrimal ductdilations). Larger balloons and higher pressures may be used fordilating revision patients (i.e., patients who have had prior ostialdilations or who's ostia have been previously modified by surgery).

The tapered end regions 46prox, 46dist are tapered at angle A relativeto the longitudinal axis LA of the catheter shaft 12 on which theballoon 14 is mounted. This angle of taper A may be in the range ofabout 10 degrees to about 30 degrees. In the particular example shown inthe drawings, such angle of taper A is 20 degrees. This 20 degree angleof taper provides improved transition from balloon working length to thenecks, lower profile, improved crossing, improved track, easierwithdrawal in the sinus guide after balloon inflation. It also providesoptimal performance with minimum increase of overall balloon length.

In some embodiments, it may be desirable for the relatively stiffproximal shaft portion 12prox to extend all the way to or near theproximal end of the balloon 14 or other dilator. Such catheter having arigid shaft from its proximal end to or near the dilator may be advanceddirectly into the sphenoid sinus ostium with or without the use of aguide catheter. In some embodiments, the proximal end of the balloon 14could be bonded to the relatively rigid proximal shaft portion 12prox.Such a construction would allow the flexible distal tip 18 to trackturns in the anatomy and may be useable to dilate certain passageways(e.g., the sphenoid sinus ostium) without disrupting the normal anatomy.Additionally, embodiments with relatively short distal shaft sections(e.g., 1-2 cm beyond the distal end of the rigid proximal shaft portionare particularly suitable for dilating the ostia of frontal sinuses.Also, in some embodiments, the proximal shaft section 12prox may bemalleable so that it may be shaped (e.g., bent or formed to a desirecurve or multi-curvate shape) to facilitate access to any desiredpassageways or locations.

Endoscopically Visible Markers and Anti-Glare Coatings

An additional visible marker 19 may optionally be formed on the proximalend of the balloon 14 and/or on the distal shaft portion 12dist, such asat the location where the proximal end of the balloon 14 is bonded tothe distal shaft portion 12dist.

These visible markers 19, 24, 26 are preferably of a color (e.g., blackor blue) that contrasts with the pink color of the nasal mucosa so as tobe easily visible within the nose. The optional marker 19 on theproximal end of the a balloon 14 allows the operator to endoscopicallyview the proximal end of the balloon even when the remainder of theballoon is within the ostium of a paranasal sinus. The other visiblemarkers 24, 26 formed on the proximal shaft are specifically designedfor use in conjunction with a guide catheter as will be discussed indetail herebelow.

In some cases, endoscopic images obtained of the markers or otherportions of the guidewires GW, guide catheter 40 a-40 f or dilationcatheter 10 may have areas of glare which can obscure visualization ofcertain portions of the markers or devices during performance of theprocedure. To minimize such glare, an anti-glare (e.g., anti-reflective)treatment or coating may be applied to all or part of the sinus guidecatheter 40 a-40 f, sinus guidewire GW and/or dilation catheter 10. Suchanti-glare treatment could be applied by etching or sand-blasting andtherefore does not add profile to the device. Such anti-glare coatingcould be applied by dip or spray coating and is very thin. The treatmentor coating does not change the mechanical or functional properties ofthese devices. It may be selectively applied. For example, a blackpolytetrafluoroethylene (PTFE) coating on the sinus guidewire GW mayprovide good anti-reflective characteristics. Some of the commerciallyavailable anti-glare or anti-reflective coating can be applied. In someembodiments, an anti-glare surface treatment (e.g., roughening, etching,etc.) may be used or an anti-glare component such as a sheath, ring,paint, etc. may be used.

The advantages and benefits of including visible markers and/or theanti-glare coating include, improved endoscopic visualization, safer andeasier performance of the procedure, reduced balloon burst or damage tocritical structures, accuracy of placement of devices and reducedfluoroscopy time or elimination of fluoroscopy.

Dilation Catheter/Guide Catheter System

FIG. 2 shows a series of sinus guide catheters 40 a-40 f that may beused in conjunction with the dilation catheter 10. These guide catheters40 a-40 f are substantially rigid and each has a preset distal curve of0 degrees (40 a), 30 degrees (40 b), 90 degrees (40 d), 70 degrees (40c) or 110 degrees (40 e and 40 f). Different curvatures are useable toaccess the ostia of different sinuses. For example, a 70 degree guide istypically used to access the ostium of a frontal sinus, a 90 or 110degree guide is typically used to access the ostium of a maxillarysinus, etc. Each of these guide catheters 40 a-40 f has a length of 12.7cm. These sinus guide catheters are described in parent United StatesPatent Application Serial Nos. and are now commercially available asRelieva® sinus guide catheters from Acclarent, Inc., Menlo Park, Calif.

FIG. 5 shows a system comprising a guide catheter 40 c having a 90degree curve formed therein in combination with a dilation catheter 10shown in FIG. 1. In optimizing the relative lengths of the proximalshaft section 12prox and distal shaft section 12dist, applicants havedetermined that, even the maximum distance that the distal end of thedilation catheter of this example is required travel beyond the distalend of the guide catheter 40 a-40 c is approximately 2.5 cm. However, itwill be appreciated that this is just one example. For otherapplication, travel beyond 2.5 cm may be desirable or necessary. Also,it is desirable for the entirety of the more flexible distal shaftsection 12dist to be advanceable into the guide catheter 40 a-40 fproximal to any curve formed in the guide catheter. With theseobjectives in mind, the example of the dilation catheter 10 shown in thedrawings has a shaft that is about 20 cm in length, with the proximalshaft section 12prox being 11.3 cm in length and the distal shaftsection 12dist being 8.7 cm in length. Thus, prior to or during theprocedure, the entire distal shaft section 12dist of the dilationcatheter 10 may be initially advanced into the rigid guide catheter 40 cwithout the distal portion of the dilation catheter 10 passing throughthe curve of the guide catheter 40 c and with only a portion of therigid proximal shaft section 12prox of the dilation catheter 10protruding out of the proximal end of the guide catheter 40 c. Tofacilitate such positioning of the dilation catheter 10 within the guidecatheter 40 d, a first shaft marker 26 is provided on the proximal shaftsection 12prox of the dilation catheter shaft 12. The distal edge ofthis first shaft marker 26 is 2.7 cm proximal to the distal end of theproximal shaft section 12prox and 11.4 cm from the distal end of thedistal tip member 18. If the operator advances the dilation catheter 10into the guide catheter 40 c until the distal edge of the first shaftmarker 26 is flush with the proximal end of the guide catheter 40 c, theentire distal shaft portion 12dist as well as the distal-most 3 cm ofthe proximal shaft portion 12prox will be housed within the guidecatheter 40 c such that the distal end of the dilation catheter 10 islocated proximal to the curve formed near the distal end of the guidecatheter 40 c. Such positioning of the dilation catheter 10 within theguide catheter 40 c provides a guide catheter/dilation catheter assemblythat is substantially rigid from the proximal hub 16 of the dilationcatheter 10 to the distal end of the guide catheter 40 c. As a result,the operator may hold or support the entire assembly by grasping orsupporting just one location on either the dilation catheter 10 or guidecatheter 40 d. For example, the user may hold or support the entireassembly by using his fingers to grasp or support either the proximalhub of the guide catheter 40 c, the proximal hub 16 of the dilationcatheter 10 or somewhere on the proximal shaft section 12prox of thedilation catheter or on the shaft of the guide catheter 40 c. Suchrigidity also substantially eliminates the potential for theexteriorized portion of the dilation catheter 10 to droop down onto thesubject's chest or onto the adjacent operating table.

As explained above, in this example, the rigid proximal shaft segment12prox of the dilation catheter 10 is 11.3 cm in length and the guidecatheter 40 d is 12.7 cm in length. Thus, when inserted into thesubject's body, the overall length of the portion of the system thatremains exteriorized (e.g., the proximal part of the guide catheter 10extending out of the subject's nose and and the proximal part of thedilation catheter 10 extending out of the proximal end of the guidecatheter 40 c) is not only rigid, but sufficiently short (e.g.,typically less than 9 cm) to be easily manageable and capable of beingheld or supported by a single hand of the operator, thereby allowing theoperator's other hand to be used for other purposes, such as foradvancing/retracting the guidewire GW or advancing/retracting thedilation catheter 10 in the manner described herebelow in connectionwith FIGS. 9-11.

The second shaft marker 24 correlates to the position of the balloon. Ifthe dilation catheter 10 is advanced to a position where the distal edgeof the second shaft marker 24 is flush with the proximal end of theguide catheter 10, the distal tip of the balloon catheter will be flushwith the distal tip of the guide catheter 40 d. When the proximal edgeof the second shaft marker 24 is flush with the proximal end of theguide catheter 10, the entire balloon 14 will have advanced out of thedistal end of the guide catheter 40 d and the operator will know that itis safe to inflate the balloon. Typically, as seen in FIG. 5, theballoon 14 is advanced some distance out of the distal end of the guidecatheter 40 d until the balloon 14 is positioned within the sinus ostiumSO or other passageway to be dilated. As seen in the enlarged view ofthe balloon 14 shown in FIG. 1B, proximal and distal radiographicmarkers 40, 42 are provided on the catheter at either end of thecylindrical segment 44 of the balloon. A C arm fluoroscope may bepositioned and used to image those proximal and distal markers 40, 42 aswell as the sinus ostium SO and the position of the dilation catheter 10may be adjusted as needed until the sinus ostium SO is midway betweenthe proximal and distal radiographic markers 40, 42. Thereafter, aninflator 50 attached to the side arm Luer connector 22 may be used toinflate the balloon 14, thereby dilating the sinus ostium SO as shown inFIG. 5. In keeping with the operator's ability to use a single hand tohold or support the exteriorized portion of the system, the inflator 50may be attached to the side arm Luer connector 22 in advance and may becontrolled by a foot pedal which is actuated by the operator's foot.

In some applications of the system shown in FIG. 5, an endoscope may beplaced in the nose and used to view all or part of the procedure.Because the exteriorized portion of the system is substantially rigidand is typically less than 15 cm in length, the operator may use asingle hand to hold the endoscope as well as the dilation catheter/guidecatheter system. Alternatively, a scope holder may be used to hold theendoscope in a fixed position while the operator positions and uses thesystem seen in FIG. 5. Alternatively, an optional handle may be used asshown in FIGS. 3-4, 6 and 8A-8B and described below.

Optionally, a member 61 may be attached to the guidewire. Such membermay serve to prevent the dilation catheter 10 and/or guide catheter 40a-40 f from inadvertently sliding off of the proximal end of theguidewire. Also, such member 61 may limit the length of guidewire GWthat may be advanced through the dilation catheter 10. This will preventthe operator from advancing too much of the guidewire GW into thesubject's sinus, as may injure or damage the mucosa lining the sinuscavity. In some embodiments, this member 61 may be a standard guidewiretorquer of the type commercially available an well known in the fieldsof interventional cardiology and/or radiology. One example of acommercially available guidewire torquer that is useable in thisapplication is a two part torquer available as Part No. 97333 fromQosina, Corp., Edgewood, N.Y.

Alternatively, the member 61 may comprise a guidewire stop/connectorapparatus 61 a as shown in FIGS. 7A-7B. This stop/connector apparatus 61a comprises a rigid plastic body 63 having a lumen extendingtherethrough and a tapered elastomeric tube member 65 on its distal end.The stop/connector apparatus 61 a is advanced over the guidewire GW tothe desired location. The inner diameter of the tapered elastomeric tubemember 65 fits snuggly on the guidewire thereby holding thestop/connector apparatus 61 a as seen in FIG. 7A. The guidewire GW issubsequently advanced through the dilation catheter 10 until the taperedelastomeric tube member 65 is received within and frictionally engagesthe proximal female Luer connector 20 on the hub of the dilationcatheter, as shown in FIG. 7B. This limits advancement of the guidewireGW and also frictionally locks the guidewire GW to the dilation catheter10 so that the operator may move both the guidewire GW and the dilationcatheter 10 as a unit. If the operator decides to advance more of theguidewire into the sinus, the operator may grasp and move thestop/connector apparatus 61 a by applying sufficient force to overcomethe frictional engagement between the stop/connector apparatus 61 a andthe guidewire GW and/or between the stop/connector apparatus 61 a andthe guide catheter hub. The force required to overcome such frictionalengagements will preferably be greater than the forces that wouldnormally result form routine movement and use of the system, therebyallowing the stop/connector apparatus 61 a to perform its lockingfunction while still allowing the location of the stop/connectorapparatus 61 a to be volitionally adjusted by the operator whennecessary.

Alternatively or additionally, if desired, another stop/connectorapparatus 61 a of larger size (or another suitable locking apparatussuch as a Touhy-Borst valve) may be mounted on the rigid proximal shaftsection 21prox of the dilation catheter 10 and received within theproximal end of the guide catheter 40 a-f to limit the advancement ofthe dilation catheter 10 through the guide catheter 40 a-f and tofrictionally lock the dilation catheter 10 to the guide catheter 40 a-fin the same manner.

Dilation Catheter/Guide Catheter System With Optional Handle

FIG. 3 shows an optional handle 42 that may be attached to the guidecatheter 40 a-40 d to facilitate single-handed holding of the guidecatheter/dilation catheter system as well as an endoscope (or otherdevice). The handle shown in FIG. 3 comprises a rigid head 44 having amale Luer fitting on one end, a lumen 47 extending therethrough and ahandle member 48 extending therefrom. As seen in the exploded view ofFIG. 4, the male Luer fitting 46 may be inserted into the proximal endof the guide catheter 40 c and the guidewire GW and guide catheter 10may then be inserted through the lumen 47 of the handle head 44 andthrough the guide catheter. The handle head 44 may be clear ortransparent so that the operator may view the shaft markers 24, 26 onthe dilation catheter shaft 12 as the dilation catheter 10 is advancedthrough the handle head 44. Alternatively, the locations of the shaftmarkers 24, 26 may be adjusted on the catheter shaft 12 to take intoaccount the additional guide length added by the handle head 44. Thehandle member 48 is preferably about the size of a standard ink pen andmay be conveniently grasped by a human hand. The handle member 48 mayhave a roughened or elastomeric surface to facilitate gripping by agloved hand and to deter slippage of the handle from the operator'sgrip. The handle member 48 may be shapeable (e.g., malleable orbendable) to allow the operator to adjust the shape and/or angle of thehandle relative to the shaft of the guide catheter 40 c. In someembodiments, the handle member 48 may be pre-shaped to accommodate atypical user and allow fine tuning by individual user. Also, in someembodiments, the handle member 48 may have foam or other material on itssurface to facilitate grip. The handle member 48 may have variousdifferent cross sectional profiles (e.g., round, oval, 3 sided, 4 sided,5 sided, 6 sided, etc.) The handle 48 serves to facilitate grip andcontrol to manipulate the dilation catheter along with a separate device(e.g., an endoscope or other tool) without having to use second hand. Inthis manner, the user may adjust rotation of a guide catheter whileobserving under endoscope (all with one hand) and use other hand toadvance and place the guidewire or other device. Also, in someembodiments, the handle member 48 may include finger loop(s) for easierto translate handle/device attached up/down relative to other deviceheld (e.g. scope) without need for other hand to adjust. Also, in someembodiments, a pinch valve or hole can be strategically placed in handle48 to actuate/allow control of suction or fluid delivery via handledevice (e.g., the user may pinch the handle with fingers to restrictflow through handle) or the handle 48 may have a suction hole where theuser must cover the suction hole to actuate suction through the optionalhandle 42.

Alternative embodiments of the handle are shown in FIGS. 3A, 3B and 3C.FIG. 3A shows a handle 42 a which is similar to that seen in FIG. 3, butwherein a fluid channel 52 extends from the lumen 47 downwardly throughthe head 44 a and through the handle member 48 a. A one way valve 50 isdisposed within the lumen 47, proximal to the location where the fluidchannel 52 meets the lumen 47. An irrigation and/or suction tube 54 maybe attached to the handle member 48 a to infuse fluid through or suctionfluid and debris through the fluid channel 52. The one way valve willensure that fluid infused or aspirated through the fluid channel 52 ofthe handle 42 a will not escape out of the proximal opening of the lumen47. However, this one way valve 50 does allow the guidewire GW anddilation catheter 10 to be inserted through the lumen 47, when desired.The one way valve may provide the additional benefit of maintaining theposition of the guidewire or dilatation catheter when it is inserted inthe guide handle. It will be appreciated that other types of valvesother than a one-way valve may be used as an alternative (e.g., Touhyrotating type valve, slide to compress valve, etc.) Or, some embodimentsmay have just a valve and a thumb/finger hole to control the suctionforce as described above.]

FIG. 3B shows another embodiment of an optional handle 42 b comprising aclear or transparent rigid head 44 b having a male Luer fitting 46 b onone end and a lumen 47 extending therethrough. In this embodiment, thehandle member 48 b is formed of a series or pivotally interconnectedunits 56 which allows the handle member 48 b to be conveniently formedinto various shapes as desired by the operator.

FIG. 3C shows yet another handle 42 c comprising a malleable or rigidhandle 48 c that is substantially the same as that shown in FIG. 3, butwherein a clip 58 is provided at the top end of the handle member 48 cto clip the handle member 48 c onto the shaft of the guide catheter 40 crather than inserting into the proximal end of the guide catheter.

FIG. 6 shows the system of FIG. 5 with the inclusion of the optionalhandle 42 on the proximal end of the guide catheter 40 c. FIGS. 8A and8B show examples of how a handle 42 may be used to facilitate concurrentholding of an endoscope as well as the guide catheter (or guidecatheter/dilation catheter assembly) by a single hand (i.e., the “scopehand”) of the operator. With reference to FIGS. 5 and 8A-8B, the handlehead 44 may initially be loosely inserted into the proximal hub of theguide catheter 40 c. The camera 62 and light cable 66 are attached tothe endoscope 60. While grasping the endoscope 60 in the manner shown inFIG. 8A, the operator may rotate the handle 42 relative to the guidecatheter 40 c to introduce the handle member 48 to the operator's scopehand. Alternatively, the handle member 48 could be grasped by theoperator's scope hand along with the endoscope 60 upon initialintroduction. When positioning of the endoscope 60 and guide catheter 40c have been achieved, the operator's other hand is used to push the maleLuer fitting 46 of the handle 42 firmly into the female Luer fitting onthe proximal end of the guide catheter 40 c, thereby locking the handle42 to the guide catheter 40 c. Thereafter, the operator's other hand isused to manipulate the guidewire GW and dilation catheter 10. In thismanner, the operator may maintain continuous endoscopic visualizationvia the endoscope 60 while using the guidewire GW and dilation catheterto dilate the ostium of a paranasal sinus or other passageway within theear, nose or throat. As explained in more detail below, positioning ofthe guidewire GW and/or balloon 14 (or other dilator) may be confirmedusing fluoroscopy, trans-illumination or other techniques in addition tovisualization via the endoscope 60. The guide handle 42 may also be usedto allow the operator to hold or support the guide catheter 40 c (or theentire guide catheter/dilation catheter system) while keeping his hand aspaced distance away from the guide catheter shaft so as to avoidradiation exposure to his hand during use of the fluoroscope.

In embodiments where the handle member 48 is shapeable (e.g., malleableor bendable) the shape of the handle member 48 may be modified one ormore times prior to or during the procedure to facilitate comfortablegrasping of the handle by the operator's scope hand and/or to adjust theposition or angle of the endoscope relative to the guide catheter. Inthis regard, in FIG. 8A, the handle member 48 is bent to a shape thatresults in a first angle A between the shaft of the guide catheter 40 cand the endoscope 60, and the operator's other hand is being used toadvance the guidewire GW through the lumen of the dilation catheter 10.In FIG. 8A, the handle has been modified to a different shape thatresults in a lesser angle A between the shaft of the guide catheter 40 cand the endoscope 60, and the operator's other hand is being used toadvance the dilation catheter 10 through the lumen of the guide catheter40 c.

The optional handle 42 may also be useful with other dilation cathetersand other trans-nasal devices described in any or all of the parentapplications of which this application is a continuation-in-part and/orthose currently available commercially under the trademark Relieva fromAcclarent, Inc., Menlo Park, Calif.

In some applications, the handle 42 may be designed to connect by way ofa unique or proprietary connector to the guide catheter or other device.Or, in some embodiments, the handle 42 may be pre-attached, integrallyformed with or otherwise designed as a part or portion of the guidecatheter or other device. In embodiments where the handle 42 is notdetachable from the guide catheter or other device, it may nonethelessbe rotatable and/or lockable in a desire position

Modes of Use of the System

FIGS. 9-11 are flow diagrams describing three (3) modes of use by whichthe system of the present invention may be used to dilate the ostium ofa paranasal sinus.

Mode 1—Inserting Guide Catheter, Guidewire and

Dilation Catheter Separately

In the example of FIG. 9, the dilation catheter 10 is prepared for useseparately from the guide catheter 40 a-40 f. The guide catheter 40 a-40f is initially inserted (along with an endoscope 60) and is advanced toa position that is within or near the ostium to be dilated. An endoscope60 is used to view the advancement and positioning of the guide catheter40 a-40 f and fluoroscopy may also be used to verify that the guidecatheter is properly positioned near or within the ostium. Optionally, ahandle 42 may be attached to the guide catheter 40 a-40 f as describedabove or the operator may simply grasp the guide catheter 40 a-40 f aswell as the endoscope 60 with the scope hand, thus leaving theoperator's other hand free to be used for subsequent handling andmanipulation of the other devices used in this procedure. Alternatively,a scope holder or assistant may be used to hold the endoscope 60 in thedesired position thus freeing both of the operator's hands for handlingand manipulation of the other devices.

After the guide catheter 40 a-40 f has been positioned, the operatorwill insert the distal end of the guidewire into the proximal end of theguide catheter 40 a-40 d and will advance the guidewire GW through theguide catheter 40 a-40 d such that a distal portion of the guidewire GWpasses through the sinus ostium and becomes coiled within the sinuscavity. Fluoroscopy (or any other suitable technique) may be used toverify that the guidewire has become coiled within the intended sinuscavity.

Thereafter, the proximal end of the guidewire GW is inserted into thedistal end of the dilation catheter 10 and the dilation catheter 10(with its balloon 14 or other dilator in its non-expanded state) isadvanced over the guidewire and through the guide catheter 40 a-40 d toa position where the dilator 14 is positioned within the sinus ostium.The endoscope 60 may be used to view the advancement and positioning ofthe dilation catheter 10. Although the distal portion of the balloon 14or other dilator will be within the sinus and out of the field of viewof the endoscope 60, the endoscope 60 may be used to view the proximalend of the balloon 14 or other dilator and/or the optional marker 19 (ifpresent) on the proximal end of the balloon 14 or other dilator.Fluoroscopy may be used to image the radiographic markers 40, 42 and theostium to confirm that the mid-region 44 of the balloon 14 (or theappropriate portion of any other type of dilator) is positioned withinthe ostium.

After the balloon 14 or other dilator has been positioned within theostium, the balloon is inflated (or the other dilator is expanded)thereby dilating the ostium.

The balloon is then deflated (or the dilator is returned to itsnon-expanded state) and the successful dilation of the ostium may beconfirmed visually using the endoscope 60 and/or radiographically usinga fluoroscope.

Thereafter, the dilation catheter 10, guidewire GW and guide catheter 40a-40 f are removed.

Mode 2—Preloading Dilation Catheter Into Guide Catheter Then

Inserting Guidewire Separately

In the example of FIG. 10, the dilation catheter 10 is prepared for useand is pre-inserted into the guide catheter 40 a-40 f to a positionwhere the first shaft marker 24 is flush with the proximal end of theguide catheter. When so positioned all of the flexible distal shaftportion 12dist and a bit of the rigid proximal shaft portion 12prox willbe within the guide catheter 40 a-40 f.

Thereafter, the guide catheter 40 a-40 f in combination with thepre-inserted dilation catheter 10 is inserted transnasally (along withan endoscope 60) and is advanced to a position that is within or nearthe ostium to be dilated. The endoscope 60 is used to view theadvancement and positioning of the guide catheter 40 a-40 f andfluoroscopy may also be used to verify that the guide catheter isproperly positioned near or within the ostium. Optionally, a handle 42may be attached to the guide catheter 40 a-40 f as described above orthe operator may simply grasp the guide catheter 40 a-40 f as well asthe endoscope 60 with the scope hand, thus leaving the operator's otherhand free to be used for subsequent handling and manipulation of theother devices used in this procedure. Alternatively, a scope holder orassistant may be used to hold the endoscope 60 in the desired positionthus freeing both of the operator's hands for handling and manipulationof the other devices.

After the guide catheter 40 a-40 f and pre-inserted dilation catheter 10have been positioned, the operator will insert the distal end of theguidewire into the proximal Luer 20 of the dilation catheter 10 and willadvance the guidewire GW through the dilation catheter 10, out of thedistal end of the guide catheter 40 a-40 d and through the sinus ostium,causing a distal portion of the guidewire to become coiled within thesinus cavity. Fluoroscopy (or any other suitable technique) may be usedto verify that the guidewire has become coiled within the intended sinuscavity.

Thereafter, the dilation catheter 10 (with its balloon 14 or otherdilator still in its non-expanded state) is advanced over the guidewireGW to a position where the balloon 14 or other dilator is positionedwithin the sinus ostium. The endoscope 60 may be used to view theadvancement and positioning of the dilation catheter. Although thedistal portion of the balloon 14 or other dilator will be within thesinus and out of the field of view of the endoscope 60, the endoscope 60may be used to view the proximal end of the balloon 14 or other dilatorand/or the optional marker 19 (if present) on the proximal end of theballoon 14 or other dilator. Fluoroscopy may be used to image theradiographic markers 40, 42 and the ostium to confirm that the midregion44 of the balloon 14 (or the appropriate portion of any other type ofdilator) is positioned within the ostium.

After the balloon 14 or other dilator has been positioned within theostium, the balloon is inflated (or the other dilator is expanded)thereby dilating the ostium.

The balloon is then deflated (or the dilator is returned to itsnon-expanded state) and the successful dilation of the ostium may beconfirmed visually using the endoscope 60 and/or radiographically usinga fluoroscope.

Thereafter, the dilation catheter 10, guidewire GW and guide catheter 40a-40 f are removed.

Mode 3 Preloading Guidewire and Dilation Catheter Into Guide Catheter

In the example of FIG. 11, the dilation catheter 10 is prepared for useand the distal end of the guidewire is pre-inserted into the proximalLuer 20 of the dilation catheter 10 and advanced to a position where thedistal end of the guidewire is within protruding just slightly out ofthe distal end of the dilation catheter 10. The dilation catheter 10,with the pre-inserted guidewire GW, is pre-inserted into the guidecatheter 40 a-40 f and advanced to a position where the first shaftmarker 24 is flush with the proximal end of the guide catheter. When sopositioned all of the flexible distal shaft portion 12dist and a bit ofthe rigid proximal shaft portion 12prox will be within the guidecatheter 40 a-40 f.

Thereafter, the guide catheter 40 a-40 f with the dilation catheter 10and guidewire pre-inserted therein is inserted through a nostril (alongwith an endoscope 60) and is advanced to a position that is within ornear the ostium to be dilated. The endoscope 60 is used to view theadvancement and positioning of the guide catheter 40 a-40 f andfluoroscopy may also be used to verify that the guide catheter isproperly positioned near or within the ostium. Optionally, a handle 42may be attached to the guide catheter 40 a-40 f as described above orthe operator may simply grasp the guide catheter 40 a-40 f as well asthe endoscope 60 with the scope hand, thus leaving the operator's otherhand free to be used for subsequent handling and manipulation of theother devices used in this procedure. Alternatively, a scope holder orassistant may be used to hold the endoscope 60 in the desired positionthus freeing both of the operator's hands for handling and manipulationof the other devices.

After the guide catheter 40 a-40 f and pre-inserted dilation catheter 10and guidewire GW have been positioned, the operator will advance theguidewire out of the distal end of the guide catheter 40 a-40 f andthrough sinus ostium, causing a distal portion of the guidewire tobecome coiled within the sinus cavity. Fluoroscopy (or any othersuitable technique) may be used to verify that the guidewire has becomecoiled within the intended sinus cavity.

Thereafter, the dilation catheter 10 (with its balloon 14 or otherdilator still in its non-expanded state) is advanced over the guidewireGW to a position where the balloon 14 or other dilator is positionedwithin the sinus ostium. The endoscope 60 may be used to view theadvancement and positioning of the dilation catheter. Although thedistal portion of the balloon 14 or other dilator will be within thesinus and out of the field of view of the endoscope 60, the endoscope 60may be used to view the proximal end of the balloon 14 or other dilatorand/or the optional marker 19 (if present) on the proximal end of theballoon 14 or other dilator. Fluoroscopy may be used to image theradiographic markers 40, 42 and the ostium to confirm that the midregion44 of the balloon 14 (or the appropriate portion of any other type ofdilator) is positioned within the ostium.

After the balloon 14 or other dilator has been positioned within theostium, the balloon is inflated (or the other dilator is expanded)thereby dilating the ostium.

The balloon is then deflated (or the dilator is returned to itsnon-expanded state) and the successful dilation of the ostium may beconfirmed visually using the endoscope 60 and/or radiographically usinga fluoroscope.

Thereafter, the dilation catheter 10, guidewire GW and guide catheter 40a-40 f are removed.

Although the above described examples refer to use of a guide catheter40 a-40 d and/or guidewire GW to guide the advancement of the dilationcatheter 10 to its intended position within the ear, nose or throat, itis to be appreciated that in some subjects and/or in some applications,the dilation catheter may be advanceable or maneuverable to its intendedposition without the use of a guide catheter 40 a-40 f and/or guidewireGW. For example, in some subjects, the dilation catheter 10 may beadvanced into the sphenoid sinus ostium without the use of a guidewireGW or guide catheter 40 a-40 d. Alternatively the flexible balloonportion may be manipulated with forceps to enable insertion in theostium. Similar techniques may apply to access of the frontal andmaxillary ostium.

The fact that the system described herein includes a guide catheter 40a-40 f that is separate from the dilation catheter 10 has certainadvantages. For example, by having two separate devices, the operatorhas separate control of the guide placement and may, in some cases,elect not to actually advance the guide into the ostium or recess beforethe ostium. Rather, the operator may in some instances elect to maneuverthe guide catheter 40 a-40 f to a position that is close to (e.g.,aligned with) but not within the ostium or recess, and may then advancedjust the relatively flexible dilation catheter 10 into the ostium orrecess. This may avoid damage tissue, bone or other anatomicalstructures. Thus, the use of a guide that is separate from the dilationcatheter allows flexibility of positioning and potentially less traumathan where a single rigid device (e.g., a rigid shafted dilationcatheter) must be navigated to the desired location and then actuallyinserted into the ostium or other passageway to be dilated.

Alternative Embodiment of a Balloon Dilation Catheter

FIGS. 12-12B show another example of a balloon dilation catheter device70. In this embodiment, the dilation catheter device 70 includes anelongate catheter shaft 72 having a proximal shaft section 72prox thatis substantially rigid and a distal shaft section 72dist that is moreflexible than the proximal shaft section 72prox. An expandable dilator,such as a balloon 74, or other suitable mechanical or non-inflationaldilator, is mounted on the distal shaft section 72dist, and a distal tipmember 78 protrudes beyond the distal end of the balloon 74, as shown.Also, a proximal T hub 76 is attached to the proximal end of theproximal shaft section 72prox. This proximal T hub has a proximal Luerconnector 80 and a side arm 82 having a female Luer connector thatextends substantially perpendicular to the longitudinal axis of the hub76, as shown. When compared to a typical Y hub, the side arm 82 of thisT hub is further away from the proximal Luer connector 80 and isoriented at a right angle to the proximal Luer connector 80. Thus,tubing connected to this perpendicular side arm 82 is less likely toobscure or block the proximal Luer connector 80 than in a typical Y huband the operator is less likely to confuse the proximal Luer connector80 with the Luer connector on the side arm 82.

In various embodiments, the overall length of the catheter shaft 72 maybe in the range of about 24 cm to about 30 cm and in one embodimentabout 25 cm. The proximal shaft section 72prox may have a length in therange of about 9 cm to about 15 cm, and the distal shaft section 72distmay have a length in the range of about 5 cm to about 10 cm. In theembodiment shown in FIG. 12, the catheter shaft 72 has an effectivelength of 18.9 cm ±0.3 cm, and an overall length of 20.0 cm ±0.5 cm.Further, the proximal shaft section 72prox is 11.1 cm ±0.2 cm in lengthand the distal shaft section 72dist has a flexible length of 7.75 cm±0.3 cm in length. The flexible length is measured from the proximal endof the distal shaft section to the distal shoulder 75dist of the balloon74.

The “ineffective tip length” of the distal shaft section 72dist, fromthe distal shoulder 75dist of the balloon to the end of the distal tipmember 78, is 1.1 cm ±0.2 cm for a 7 mm balloon. For different balloonsizes, the ineffective tip length is 0.75 cm ±0.2 cm for a 3.5 mmballoon, 0.9 cm ±0.2 cm for a 5 mm balloon, and 1.0 cm ±0.2 cm for a 6mm balloon. Also, the distal tip member 78 is atraumatic and may have aradius shaped distal end.

Referring now to the cross sectional view of FIG. 12A, the proximalshaft section 72prox may include a rigid outer tube 90, a flexiblemiddle tube 92 disposed substantially coaxially within the lumen of therigid outer tube 90, and an inner tube 96 disposed substantiallycoaxially within the lumen of the middle tube 92. In this embodiment,the outer tube 90 is formed of stainless steel hypotube or support tubehaving an outer diameter of about 0.076 inches and an inner diameter ofabout 0.068 inches. The relatively larger outer diameter of outer tube90 compared to the outer tube 30 of balloon catheter 10, helps decreasethe inflation time of the balloon 74. As an alternative to stainlesssteel hypotube, this outer tube 90 may be formed of rigid non-metallicmaterial such as polyetheretherketone (PEEK) or other rigid plasticssuitable for such application. Alternatively, other rigid reinforcingmembers may be used in, or in lieu of, the outer tube, such as wires(round, flat, square or of other cross section), partial tubes (e.g.,arcs), etc. Also, in this particular example, the middle tube 92 isformed of Pebax having an inner diameter of 0.055 inches, an outerdiameter of 0.065+1-0.003 inches. The inner tube 96 is formed ofpolyether block copolymer tubing (e.g., Pebax® Resin, Arkema, Inc.,Philadelphia, Pa.) having an inner diameter of at least 0.036 inches,and preferably having an inner diameter of 0.038 inches and an outerdiameter of 0.048 inches. Having an inner tube 96 with an inner diameterof at least 0.036 inches allows the balloon catheter 70 to be compatiblewith multiple types of guidewires, including a lighted guidewire, suchas the Acclarent Relieva Luma™ Sinus Illumination Guidewire, which hasan outer diameter of 0.0354 inches.

The outer tube 90 terminates at the end of the proximal shaft section72prox. The middle tube 92 and inner tube 96 extend beyond the distalend of the outer tube 90, forming the distal shaft section 72dist.

As seen in FIG. 12A, a polyether block copolymer film laminate 91 (e.g.,Pebax® Resin, Arkema, Inc., Philadelphia, Pa.) is heat shrunk onto theouter surface of the catheter shaft 72 from the proximal hub 76 to theballoon 74. This laminate 91 provides a smooth outer surface andsmoothes the step-down in diameter from the distal end of the proximalshaft section 72prox to the proximal end of the distal shaft section72dist (i.e., it provides a smooth surface over the distal end of theouter tube 90 and the adjacent outer surface of the middle tube 92). Thesmooth step down may also be formed by an adhesive fillet. In otherembodiments, the smooth step down may be formed by tapering orchamfering the structure of the distal end of the proximal shaft,eliminating the need for a laminate or adhesive.

The proximal end of the middle tube 92 extends into and is secured tothe hub 76, distal to side arm Luer connector 82. The proximal end ofthe inner tube 96 extends into and is secured within hub 76, proximal tothe side arm Luer connector 82 and in direct alignment and fluidcommunication with proximal Luer connector 80. The distal end of themiddle tube 92 terminates within the balloon 74 and the proximal end ofthe dilator is secured to the outer surface of the middle tube. Thedistal end of the inner tube 96 also extends through the balloon 74 andprotrudes distally beyond the balloon 74, forming the relativelyflexible distal tip member 78 as shown in FIG. 12. The distal end of theballoon 74 is secured to the outer surface of the inner tube 96. In thismanner, the inner tube lumen 98 extends through the entire cathetershaft 72 from the proximal Luer connector 80 through the distal tip 78and may be used as a guidewire lumen or as a working lumen for infusionof irrigation solution, medicaments, contrast media or other substancesand/or for aspiration of blood, fluids or debris. Guidewires that may beadvantageously used in conjunction with this dilation catheter 70 mayhave a length of 60 cm to 80 cm Ser. No. 12/496,226, issued as U.S. Pat.No. 9,399,121 on Jul. 5, 2016, and may be either 0.014 inch or 0.035inch, such as those commercially available as the Relieva® SinusGuidewires (Acclarent, Inc., Menlo Park, Calif.) or sizes in betweensuch as 0.018 inch, 0.020 inch, or 0.033 inch. Although the drawingsshow an over-the-wire catheter having a guidewire lumen that extendsthrough the entire length of the catheter, it is to be appreciated thatguidewire lumens extending less than the entire length of the catheter(e.g., rapid exchange guidewire lumens) may be used as an alternative tothe over-the-wire lumen shown. Additionally, in some embodiments, ratherthan advancing the catheter over a guidewire, the catheter may beequipped with a fixed guidewire tip such as any of those described inU.S. patent application Ser. No. 11/438,090, issued as U.S. Pat. No.8,951,225 on Feb. 10, 2015, entitled Catheters with Non-Removable GuideMembers Useable for Treatment of Sinusitis, the entire disclosure ofwhich is expressly incorporated herein by reference.

The inner tube lumen 98 may be lined or coated with a lubriciousmaterial to facilitate passages of the guidewire GW through that lumen98. The diameter of the inner tube 96 may be changed to accommodateguidewires of different diameter. In the particular embodimentdescribed, the inner tube lumen 98 is sized to receive a 0.035 inchdiameter guidewire GW. The inner tube lumen 98 may be internally linedor coated with a 2% solution of linear polydimethylsiloxane (PDMS)(e.g., Dow Corning® 360 Medical Fluid, Dow Corning Corporation, Midland,Mich.) diluted in isopropyl alcohol or another silicone material (suchas a 2% solution of Dow-Corning MDX4-4159 in isopropyl alcohol). Thecoating is cured at room temperature.

The luminal space 94 between the outer surface of the inner tube 96 andthe inner surface of the middle tube 92 is in fluidic communication withthe side arm Luer connector 82 and extends to the interior of theballoon 74. Thus, this luminal space 94 serves as the passageway throughwhich inflation fluid is passes into and out of the balloon 74. The sizeof this luminal space 94 and the relatively short length of the cathetershaft 72 are optimized to minimize drag on inflation fluid passingthrough this luminal space 94 and allows for rapid deflation of theballoon 74. The clearance of 0.006 to 0.007 inches between the inner andouter member is desired for catheter length of 20-35 cm. The desireddeflation time is less than or equal to about 5 seconds and thedeflation time is measured with application of negative pressure on theinflation/deflation lumen using a 20 cc inflation device that is filledwith 10 cc contrast/saline mixture.

FIG. 12B shows details of the balloon 74. In this embodiment, theballoon 74 is a non-compliant balloon formed of polyethyleneteraphthalate (PET) film having a thickness of 0.8 mils. The balloon 74has a triangular or tri-fold (or approximately triangular)cross-sectional shape 104 in a partially inflated state. In alternativeembodiments, the balloon 74 may have any suitable geometry in apartially inflated state, such as a round shape or any suitablenon-round shape. The approximately triangular shape 104 may facilitatewrapping and/or re-wrapping the balloon 74 around the outer tube 90. Inuse, the triangular cross-sectional shape of the balloon allows theballoon, when deflated, to more easily re-wrap and pass back through theguide catheter for removal from a patient. Various balloon catheters 70having variously sized balloons 74 may be provided, such as but notlimited to the following sizes (diameter x effective length of theballoon in millimeters): 5×16, 6×16, 7×16, 5×24, 7×24, 3.5×12. Otherballoon sizes may also be available. The working length (or “effectivelength”) of the balloon is measured from a proximal shoulder 75prox to adistal shoulder 75dist of the balloon 74. In some embodiments, a numberof catheters having a number of balloon sizes may be provided to a user,so that the physician user may choose one or more sizes based on theanatomy to be treated, physician preference and/or the like. In oneembodiment, the balloon 74 may have a rated burst pressure of at leastabout 10 to about 16 atmospheres and preferably about 14 to about 16atmospheres.

The balloon 74 also includes tapered proximal and distal end regions106prox and 106dist. In some embodiments, each of the two tapered endregions 106prox, 106dist may have the same length. This length of thetapered regions 106prox, 106dist may be different for differently sizedballoons 74. For example, in one set of balloon 74 embodiments, aballoon 74 having a diameter of at about 7 mm may have a taper length ofabout 6 mm, a balloon 74 having a diameter of at about 6 mm may have ataper length of about 5 mm, a balloon 74 having a diameter of at about 5mm may have a taper length of about 4 mm, and a balloon 74 having adiameter of at about 3.5 mm may have a taper length of about 2.5 mm.

The tapered end regions 106prox, 106dist are tapered at angle A relativeto the longitudinal axis LA of the catheter shaft 72 on which theballoon 74 is mounted. This angle of taper A may be in the range ofabout 10 degrees to about 30 degrees. In the particular example shown inthe drawings, such angle of taper A is 20 degrees. This 20 degree angleof taper provides improved transition from balloon working length to thenecks, lower profile, improved crossing, improved track, easierwithdrawal in the sinus guide after balloon deflation. It also providesoptimal performance with minimum increase of overall balloon length.

As best shown in FIG. 12B, the balloon 74 includes an extended balloonneck 77. In this embodiment, the balloon neck is about 1 cm in length. Aproximal end of the balloon neck 77 may be bonded to the distal shaftportion 72dist. The extended balloon neck provides a separation betweenthe bond to the shaft 72 and the tapered end region 106prox. Thisseparation allows a marker to be disposed on the shaft and aligned withthe proximal end of the balloon (at the proximal taper) without beingdisposed on or near the bond (adhesive) that secures the balloon to theshaft.

As shown in FIGS. 12 and 12B, in some embodiments, direct visualizationmarkers and/or radiographic markers may be disposed along the cathetershaft 72. Generally, “direct visualization markers” refers to markersthat may be viewed during use with the naked eye or by use of anendoscope, while radiographic markers include radiopaque material andare viewed using a radiographic device such as intra-operativefluoroscopy. In one embodiment, at the distal end, there is a firstdistal radiographic marker 110 a, which has a proximal edge aligned withthe location where the proximal taper 106prox meets the effective lengthof the balloon 74. There is also a second distal radiographic marker 110b, which has a distal edge aligned with the location where the distaltaper 106distal meets the effective length of the balloon 74. Thedistance across the outside edges of the distal markers 110 a and 110 bis about 1.6 cm ±0.2 cm and represents the effective length of theballoon 74. The distal markers 110 a and 110 b may be platinum markerbands. In this embodiment, the distal markers help to ensure that theballoon catheter 70 is in a straight position inside the guide duringthe device loading and preparation.

Direct visualization markers can be positioned in a number of locationsalong the catheter shaft 72. Although one embodiment is described herewith reference to FIGS. 12 and 12B, other variations may be substitutedin alternative embodiments. In one embodiment, shaft 72 may have a darkcolor, such as black, dark blue, dark grey or the like, and markers mayhave a light color, such as white, green, red or the like. In someembodiments, markers may have different colors and/or different widthsto facilitate distinguishing the markers from one another during use.This contrast in colors may facilitate viewing the markers in a darkenedoperation room and/or when using an endoscope inside a patient in thepresence of blood.

In one embodiment, there may be a first distal shaft marker 112 (or“endoscopic marker,” since it is typically viewed during use via anendoscope) disposed on the shaft 72 at a location such that its distaledge aligns with the location where the proximal taper of the balloon 74meets the catheter shaft 72. The extended balloon neck 77 allows thefirst endoscopic marker 112 to be placed on the shaft and away from anyadhesive bonding used to secure the proximal end of the balloon neck tothe shaft. The first endoscopic marker 112 indicates to the user theending location of the balloon 74 and indicates that the balloon hasexited the guide during a procedure. In one embodiment, the firstendoscopic marker 112 may be about 2 mm wide.

A second distal shaft marker 114 is disposed on the shaft 72 such thatthe distal edge of the marker is 1 cm ±0.2 cm from the location wherethe proximal taper of the balloon 74 meets the catheter shaft 72. Thismarker indicates to the user that the shaft location is 1 cm away fromthe end of the balloon indicating that the balloon has extended from theguide during the Docket No. 83529.0056 procedure. In one embodiment, thesecond distal shaft marker may be about 2 mm wide and white in color,while the first marker is about 2 mm and green in color. Of course, anyof a number of different size and color combinations may be usedalternatively.

A third distal shaft marker 116 is disposed on the shaft 72 such thatthe distal edge of the marker is 1 cm ±0.1 cm from the distal edge ofthe second distal shaft marker 114. As shown in FIG. 12B, the thirddistal shaft marker is a double marker to distinguish the second andthird distal shaft markers 114 and 116 from one another. The thirddistal shaft marker 116 indicates the shaft location 2 cm away from theend proximal end of the balloon 74, thus indicating the distance theballoon has extended from the guide during the procedure. In oneembodiment, the two markers forming the third distal shaft marker 116are each 0.75 mm wide and white in color, however, the size and color ofthe marker can be changed in alternative embodiments. The differences inthe first, second and third distal shaft markers' color, length andnumber of marks give the indication of the relative location proximal tothe balloon under endoscopic visibility. Using an endoscope, thephysician user can identify the length of catheter that has beenadvanced and retracted out of a guide catheter and/or can approximate alocation of the balloon 74 relative to patient anatomy such as aparanasal sinus ostium, other paranasal sinus opening, or other openingsin the ear, nose or throat. This approximation of balloon position maybe very useful in circumstances when the balloon 74 has been advancedfar enough into an anatomical location that the balloon 74 can no longerbe viewed via endoscope. For example, using the three endoscopicmarkers, the user is able to endoscopically gauge the distance thecatheter has advanced into the frontal recess once the proximal portionof the balloon is no longer visible. Of course, in alternativeembodiments, distal shaft markers having different numbers, sizes,colors and positions along the catheter shaft may be used.

In some embodiments, in addition to one or more distal shaft markers,one or more proximal shaft markers may be disposed along the proximalportion of catheter shaft 72. In general, such proximal shaft markersmay be viewed directly by a physician, without using an endoscope, toindicate to the physician a location of the balloon 74 of the catheter70 relative to a guide catheter through which the balloon catheter 70 isbeing advanced. As with the distal shaft markers, the proximal shaftmarkers may have any suitable width, color, number, position and thelike. In one embodiment, for example, as shown in FIG. 12, two proximalshaft markers 118, 120 may have a light color to contrast with a darkcolored shaft 72 and increase visibility in a darkened operating room.The more proximal of the proximal markers 118 (or the “first proximalshaft marker”) may indicate that a tip of the balloon catheter 74 is ata distal end of the guide catheter and that the balloon 74 has exitedthe distal end of the guide catheter as the marker 118 passes into theproximal end of the guide catheter. The more distal of the proximalmarkers 120 (or the “second proximal shaft marker”) may indicate to auser that the balloon 74 is just proximal to a curve in a guide catheterwhen marker 120 is located at the proximal end of the guide catheter.

In one embodiment, the first proximal shaft marker 118 is disposed onthe shaft 72 such that the length from the proximal end of the proximalballoon taper 106 to the proximal end of the first shaft marker is 13.1cm ±0.2 cm. The first proximal shaft marker is 4.1 cm ±0.1 cm in lengthfor a 7×24 mm balloon catheter. The length of the first proximal shaftmarker 118 can vary depending on the size of the bballoon catheter. Thelength of the first proximal shaft marker 118 may be determined byadding the length of the distal tip 78, the effective or working lengthof the balloon 74, and the lengths of the two balloon taper sections.Also, the first proximal shaft marker is preferably white in color,however, other light colors, such as grey, can be used as well.

The second proximal shaft marker 120 is disposed on the shaft 72distally from the first proximal shaft marker 118. The second proximalshaft marker 120 is positioned such that the distal tip of the catheter70 is 11.4 cm ±0.2 cm from the distal edge of the second proximal shaftmarker 120. Also, the second proximal shaft marker 120 has a length of 3mm ±2 mm. It is preferred that the second shaft proximal marker 120 iswhite in color, however, other light colors, such as grey, can be usedas well.

When the balloon catheter 70 is inserted into a guide, a user mayvisualize the first and second proximal shaft markers 118 and 120 todetermine the position of the distal tip and the balloon 74 of theballoon catheter 70 relative to the sinus guide catheter. For instance,when the second proximal shaft marker 120 is aligned with the proximalopening of the guide catheter, the user will know that the balloon 74 isproximal to the curve of the guide catheter. The position of the secondproximal shaft marker 120 helps to visually ensure that the ballooncatheter 70 is properly loaded into the sinus guide catheter. When thedistal edge of the first proximal shaft Docket No. 83529.0056 marker 118is aligned with the proximal opening of the guide catheter, the userknows that the distal tip of the balloon catheter 70 is beginning toexit the guide catheter, and when the proximal edge of the firstproximal shaft marker is aligned with the proximal opening of the guidecatheter, the user knows that the balloon is completely out of the guidecatheter.

The visible markers 114, 116, 118 and 120 are preferably light in color,such as white as indicated above, to contrast with a dark color of theshaft 72, which is preferably black. The high contrast between thesevisible markers and the shaft helps view the markers in a low lightenvironment. Also, the high contrast allows the user to view directlywith an endoscope the markers and know where the balloon 74 is locatedrelative to a sinus ostium. Furthermore, the color contrast is usefulduring the procedure when the field is full of blood and/or mucus toview the markers and know the position of the balloon.

The alternative embodiment of the balloon catheter 70 is used in asimilar manner to the first embodiment of the balloon catheter 10 asdescribed above. Further, separate features of the balloon catheters 10and 70 may be incorporated into or used with either embodiment.

The invention has been described with reference to certain examples orembodiments of the invention, but various additions, deletions,alterations and modifications may be made to those examples andembodiments without departing from the intended spirit and scope of theinvention. For example, any element or attribute of one embodiment orexample may be incorporated into or used with another embodiment orexample, unless otherwise specified of if to do so would render theembodiment or example unsuitable for its intended use. Also, where thesteps of a method or process have been described or listed in aparticular order, the order of such steps may be changed unlessotherwise specified or unless doing so would render the method orprocess unworkable for its intended purpose. All reasonable additions,deletions, modifications and alterations are to be consideredequivalents of the described examples and embodiments and are to beincluded within the scope of the following claims.

1.-16. (canceled)
 17. A method for dilating a drainage passagewayassociated with a paranasal sinus of a patient, the method comprising:advancing a guide catheter into a head of a patient such that a distalend of the guide catheter is positioned within or near the drainagepassageway associated with the paranasal sinus; inserting an endoscopeinto the patient's head; advancing a balloon catheter through a lumen ofthe guide catheter such that a balloon of the catheter passes out of thedistal end of the guide catheter; viewing, with the endoscope, a firstdistal shaft marker disposed on a shaft of the balloon catheter a firstknown distance from the balloon; viewing, with the endoscope, a seconddistal shaft marker disposed on the shaft a second known distance fromthe balloon; approximating a location of the balloon relative to thedrainage passageway associated with the paranasal sinus, using the firstand second distal shaft marker and their known distances from theballoon; and expanding the balloon of the balloon catheter to remodel orbreak bone underlying mucosa of the drainage passageway associated withthe paranasal sinus and dilate the the drainage passageway associatedwith the paranasal sinus.
 18. A method as in claim 17, furthercomprising viewing a first proximal shaft marker during the step ofadvancing the balloon catheter, wherein when a distal end of the firstproximal shaft marker enters a proximal end of the guide catheter adistal end of the balloon catheter shaft is located approximately at thedistal end of the guide catheter, and wherein when a proximal end of thedistal shaft marker enters the proximal end of the guide catheter aproximal end of the balloon of the catheter is located approximately atthe distal end of the guide catheter.
 19. A method as in claim 18,further comprising viewing a second proximal shaft marker during thestep of advancing the balloon catheter, wherein the second proximalshaft marker is disposed distal to the first proximal shaft marker, andwherein when the second proximal shaft marker is located approximatelyat the proximal end of the guide catheter, the distal end of the ballooncatheter is located immediately proximal to a curve in the distal end ofthe guide catheter.
 20. A method as in claim 17, wherein the firstdistal shaft marker is located proximal to the balloon and the seconddistal shaft marker is located distal to the balloon.
 21. A method as inclaim 20, wherein the first and second distal shaft markers are locatedproximal to the balloon.
 22. A method as in claim 21, wherein the firstdistal shaft marker is located approximately one centimeter proximal toa proximal end of the balloon, and the second distal shaft marker islocated approximately two centimeters proximal to the proximal end ofthe balloon.
 23. A method as in claim 22, further comprising viewing athird distal shaft marker located at the proximal end of the balloon.24. A method as in claim 17, further comprising advancing a guidewirethrough the guide and through the drainage passageway associated withthe paranasal sinus before advancing the balloon catheter, wherein theballoon catheter is advanced over the guidewire and through the guide.25. A method as in claim 17, further comprising: removing the ballooncatheter through the guide catheter; advancing an irrigation catheterthrough the guide catheter into the paranasal sinus; and irrigating thesinus using the irrigation catheter.
 26. A method for dilating adrainage passageway associated with a paranasal sinus of a patient, themethod comprising: advancing a dilation catheter comprising a balloonand a first shaft marker to a position where the first shaft marker isat or near a proximal end of a guide member; advancing the guide memberin combination with the dilation catheter into a head of the patientsuch that a distal end of the guide member is positioned at or near thedrainage passageway; advancing a distal end of a guidewire out of thedistal end of the guide member through the drainage passageway;advancing the dilation catheter relative to the guide member such thatthe balloon of the dilation catheter protrudes distally past the distalend of the guide member; and inflating the balloon to remodel or breakbone underlying mucosa of the drainage passageway and thereby dilate thedrainage passageway.
 26. A method as in claim 25, further comprisinginserting an endoscope into the patient's head and endoscopicallyviewing a second marker on a proximal end of the balloon to confirm thatthe balloon of the dilation catheter passes distally past the distal endof the guide member.
 27. A method as in claim 25, further comprisingdeflating the balloon in from 5 to 10 seconds.
 28. A method as in claim26, further comprising confirming endoscopically dilation of thedrainage passageway.
 29. A method as in claim 26, further comprising:removing the balloon catheter from the guide member; advancing anirrigation catheter relative to the guide member into the paranasalsinus; and irrigating the sinus using the irrigation catheter.
 30. Amethod for dilating a drainage passageway associated with a paranasalsinus of a patient, the method comprising: advancing a distal end of aguidewire beyond a distal end of a dilation catheter, wherein thedilation catheter comprises a balloon and a first shaft marker;advancing the guidewire in combination with the dilation catheter and aguide member into a head of the patient such that a distal end of theguide member is positioned near the drainage passageway; advancing theguidewire distally past the distal end of the guide member; advancingthe dilation catheter over the' guidewire to a position within thedrainage passageway; and inflating the balloon to remodel or break boneunderlying mucosa of the drainage passageway to thereby dilate thedrainage passageway.
 31. A method as in claim 30, further comprisingadvancing the dilation catheter with respect to the guide member until adistal edge of the first shaft marker is flush with a proximal end ofthe guide member such that the distal end of the dilation catheter islocated proximal to a curved portion of the guide member, wherein thecurved portion is at or near the distal end of the guide member.
 32. Amethod as in claim 31, further comprising pre-inserting the dilationcatheter into the guide member at a position wherein the first shaftmarker on the dilation catheter is at or near the proximal end of theguide member.
 33. A method as in claim 30, further comprisingpre-inserting the guidewire into the dilation catheter.
 34. A method asin claim 30, further comprising passing the guidewire into the paranasalsinus and coiling the guidewire within a cavity of the paranasal sinus.35. A method as in claim 30, wherein the balloon comprises a firstradiographic marker at its proximal end and a second radiographic markerat its distal end, the method further comprising fluoroscopic imaging ofthe first and second radiographic markers to confirm that the balloon ispositioned within the ostium.